When a part of tissue of body is impaired due to trauma, infection, tumor, degenerative disease, congenital disease, etc., autograft transplantation can be performed as a treating method. Autograft transplantation has a variety of advantages over allograft transplantation but has some problems as follows: requirement of more time from 30 minutes to 1 hour in operation and anesthesia for obtaining autograft tissue and suture; pain, bleeding and complication such as infection which may occur in the tissue-providing region; limitation of available graft tissue; and irregularity of tissue shape. Recently, as medical technology has developed, the demand for tissue transplantation materials is increasing in many fields such as orthopedics, neurosurgery, plastic surgery, general surgery, thoracic surgery, etc. As a result, allograft and xenograft transplantations are increasing in substitution for autograft tissue transplantation.
In allograft and xenograft tissue transplantations, two problems are intrinsically entailed. One is the possibility that infectious diseases or cancer may be propagated from a donor to a donee via transplantation materials. The other is the possibility that immune rejection response in a donee may be caused by foreign proteins or adipocytes.
Regarding the propagation of infectious diseases, it has been reported that pathogenic bacteria, fungi, virus and cancer cell are propagated from a donor to a donee via tissue transplantation. More particularly, regarding bacteria infection of donee after allograft transplantation, 1 case in 1953, 1 case in 1981, 3 cases in 1988, 1 death case in 2002, 1 case in 2003, 14 cases in sports medicine between 1988 and 2002, and 2 cases in 2006 have been reported in the U.S.A. In addition, after allograft transplantation, there was 1 case of hepatitis type B in 1954; 1 case in 1992, 2 cases in 1995; 4 cases in 2005 of hepatitis type C; 1 case in 1988, 3 cases in 1992 of acquired immunodeficiency syndrome (AIDS); Candida albicans infection in 1996; and bovine spongiform encephalopathy (BSE) infections after allograft corneal or epidural transplantation in 1974, 1981, 1987 and 1991 were reported to the U.S. CDC (Centers for Disease Control and Prevention). In case of allograft, the infectious propagation to donees has been considerably decreased by strict selection of donors; medical, social, sexual history inspection; physical test, inspection for medical record and donor serum, etc. However, infectious diseases can still be propagated because virus may not be detected in a general donor serum test if the test is conducted during the “window period,” which is the time between viral infection and generation of antibodies, or the virus is a new virus such as Severe Acute Respiratory Syndrome (SARS) coronavirus or Avian Influenza virus. Thus, in the case of using a fresh allograft or a xenograft tissue for treating the human body, the sterilization step of tissue for transplantation is absolutely required to prevent infection or cancer propagation.
Besides propagation of infectious diseases, immune rejection response after allograft or xenograft transplantation is also problematic. After tissue transplantation is performed, various cell groups existing in the transplanted material, and other materials remaining in bone such as collagen, ground substance, proteoglycan, link protein, inorganic minerals, etc. are involved in immune rejection response. They exist on the surface membrane glycoprotein of cells such as bone cells, chondrocytes, fibrous cells, vascular cells, adipocytes, nerve cells, stem cells, etc. Among the cells involved in immune rejection response in bone, leukocytes, myelocytes and adipocytes are removable without changing the structure or nature of the bone. These cell groups have a close relation to immune rejection response. Therefore, in order to increase the engraftment rate in the donee's body after allograft or xenograft transplantation and to minimize immune rejection response, such cell groups must be removed from bone as much as possible.
Tissue for transplantation can be disinfected initially by washing. The tissue may be washed by physical processing, for example, such as simple washing, centrifuge, pasteurization or sonification, etc., or by chemical processing of using various solvents, for example, such as ethanol, methanol, chloroform, iodoacetic acid, peracetic acid-ethanol, sodium hypochloride, ethylene diamine, glycerol, hydrogen peroxide, etc. However, the efficacy of each method has not yet been studied and reported sufficiently. Conventional chemical treating processes use one kind of chemical alone. Recently, the use of a combination of several kinds of chemicals has been studied to increase the efficacy.
When using one kind of chemical alone, only one kind of lipid or protein is washed, or only fraction of the bacteria or viruses existing in infected tissue are inactivated. Thus, a method of increasing the washing efficiency by properly combining the components of washing solution is needed to inactivate bacteria and viruses by destroying membranes of various cells such as bone marrow cells, erythrocytes and leukocytes.
Therefore, there has been an increased demand for a cleaning solution useful in chemical processing to minimize infection with bacteria, prions via transplanted tissue, and bone marrow cells, leukocytes, adipocytes, etc. which are known to be directly involved in immune rejection response. If such a cleaning solution is used, the infection of transplantation graft can be decreased and the engraftment rate can be improved with the use of a tissue treated by the solution in allograft or xenograft transplantation.